Patient characteristics
| Variable . | Control Subjects (n = 10) . | No GVHD (n = 10) . | GI GVHD (n = 19) . | P . |
|---|---|---|---|---|
| Sex | .41 | |||
| Male | 1 (10) | 8 (80) | 11 (58) | |
| Female | 9 (90) | 2 (20) | 8 (42) | |
| Race | .53 | |||
| White | 9 (90) | 10 (100) | 17 (89) | |
| Other | 1 (10) | – | 2 (11) | |
| Age at transplant, median (range), y | 55 (43-71) | 58 (13-67) | .89 | |
| Comorbidity index (HCT–comorbidity index) | .54 | |||
| Low risk (0) | 3 (30) | 3 (16) | ||
| Intermediate risk (1-2) | 3 (30) | 9 (47) | ||
| High risk (≥3) | 4 (40) | 7 (37) | ||
| Diagnosis | .15 | |||
| AML | 3 (30) | 11 (58) | ||
| MDS | 3 (30) | 3 (16) | ||
| ALL | – | 3 (16) | ||
| Other | 4 (40) | 2 (10) | ||
| Donor | .25 | |||
| MUD | 3 (30) | 10 (53) | ||
| MSD | 6 (60) | 4 (21) | ||
| Haploidentical | 1 (10) | 3 (16) | ||
| Cord | – | 2 (11) | ||
| Conditioning intensity | .43 | |||
| Myeloablative | 7 (70) | 9 (47) | ||
| Reduced intensity | 3 (30) | 10 (53) | ||
| Source of stem cells | .32 | |||
| Peripheral blood | 4 (40) | 11 (58) | ||
| Bone marrow | 6 (60) | 6 (32) | ||
| Cord blood | – | 2 (11) | ||
| GVHD prophylaxis | .34 | |||
| CSA or FK/MMF | 4 (40) | 10 (53) | ||
| FK/MMF/posttransplant cyclophosphamide | 1 (10) | 3 (16) | ||
| FK/MTX | – | 2 (11) | ||
| Clinical trial* | 5 (50) | 4 (21) | ||
| Grade of GVHD | – | |||
| 0 (none) | 10 (100) | – | ||
| Grade II | – | 9 (47) | ||
| Grade III | – | 8 (42) | ||
| Grade IV | – | 2 (11) | ||
| GVHD site | – | – | ||
| Lower | 4 (21) | |||
| Upper | 5 (26) | |||
| Both | 10 (52) | |||
| Time to GVHD onset, median (range), d | – | 43 (19-160) | – |
| Variable . | Control Subjects (n = 10) . | No GVHD (n = 10) . | GI GVHD (n = 19) . | P . |
|---|---|---|---|---|
| Sex | .41 | |||
| Male | 1 (10) | 8 (80) | 11 (58) | |
| Female | 9 (90) | 2 (20) | 8 (42) | |
| Race | .53 | |||
| White | 9 (90) | 10 (100) | 17 (89) | |
| Other | 1 (10) | – | 2 (11) | |
| Age at transplant, median (range), y | 55 (43-71) | 58 (13-67) | .89 | |
| Comorbidity index (HCT–comorbidity index) | .54 | |||
| Low risk (0) | 3 (30) | 3 (16) | ||
| Intermediate risk (1-2) | 3 (30) | 9 (47) | ||
| High risk (≥3) | 4 (40) | 7 (37) | ||
| Diagnosis | .15 | |||
| AML | 3 (30) | 11 (58) | ||
| MDS | 3 (30) | 3 (16) | ||
| ALL | – | 3 (16) | ||
| Other | 4 (40) | 2 (10) | ||
| Donor | .25 | |||
| MUD | 3 (30) | 10 (53) | ||
| MSD | 6 (60) | 4 (21) | ||
| Haploidentical | 1 (10) | 3 (16) | ||
| Cord | – | 2 (11) | ||
| Conditioning intensity | .43 | |||
| Myeloablative | 7 (70) | 9 (47) | ||
| Reduced intensity | 3 (30) | 10 (53) | ||
| Source of stem cells | .32 | |||
| Peripheral blood | 4 (40) | 11 (58) | ||
| Bone marrow | 6 (60) | 6 (32) | ||
| Cord blood | – | 2 (11) | ||
| GVHD prophylaxis | .34 | |||
| CSA or FK/MMF | 4 (40) | 10 (53) | ||
| FK/MMF/posttransplant cyclophosphamide | 1 (10) | 3 (16) | ||
| FK/MTX | – | 2 (11) | ||
| Clinical trial* | 5 (50) | 4 (21) | ||
| Grade of GVHD | – | |||
| 0 (none) | 10 (100) | – | ||
| Grade II | – | 9 (47) | ||
| Grade III | – | 8 (42) | ||
| Grade IV | – | 2 (11) | ||
| GVHD site | – | – | ||
| Lower | 4 (21) | |||
| Upper | 5 (26) | |||
| Both | 10 (52) | |||
| Time to GVHD onset, median (range), d | – | 43 (19-160) | – |
Data are presented as n (%) unless otherwise indicated.
ALL, acute lymphoblastic leukemia; AML, acute myelogenous leukemia; CSA, cyclosporine; FK, tacrolimus; MDS, myelodysplastic syndrome; MMF, mycophenolate mofetil; MSD, matched sibling donor; MUD, matched unrelated donor; MTX, methotrexate.
Clinical trial: 3 patients in the non-GVHD group and 3 patients in the GVHD group received FK/MMF/mini-dose MTX on a clinical trial; 2 patients in the non-GVHD group received FK/MTX/bortezomib on the BMT CTN 1203 trial, and 1 patient in the GVHD group received FK/MTX/maraviroc on the BMT CTN 1203 trial.